AFX Endovascular AAA System BA28-60/I16-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00818009010216), received between Sep 29, 2016 and Feb 6, 2020 — classified as 1 death, 5 injuries.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (3 reports).

16 other recalls cover devices cleared under the same FDA submission (P040002); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2020Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION AND TWO (2) LIMB STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE (THE EXACT DATE OF EVENT WAS NOT PROVIDED), A SALES REPRESENTATIVE OF ENDOLOGIX WAS INFORMED BY A COMPETITOR (GORE) SALES REPRESENTATIVE THAT THIS PATIENT WAS GOING TO BE HAVE A RE-INTERVENTION WITH NON - ENDOLOGIX (GORE) DEVICES IN EARLY (B)(6) 2020 DUE TO A REPORTED TYPE 3B ENDOLEAK. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Failure of Implant

  MAUDE report 9678888 ↗
• InjuryJan 17, 2020Use of Device Problem; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Use of Device Problem; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  THE PATIENT WAS INITIALLY TREATED FOR AN ILIAC ANEURYSM WITH THE AFX ABDOMINAL AORTIC ANEURYSM (AAA) STENT; THIS IS AN OFF-LABEL INITIAL IMPLANT AS AFX IS INTENDED FOR AAA TREATMENT. APPROXIMATELY FOUR AND A HALF YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH TYPE IA AND II ENDOLEAKS AS DETECTED PER CT (COMPUTED TOMOGRAPHY) AT ROUTINE FOLLOW-UP. THE PHYSICIAN PLANS TO RE-INTERVENE AND SURGERY IS SCHEDULED FOR (B)(6)2020. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9603642 ↗
• InjuryApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND VELA INFRARENAL ON (B)(6) 2014. A SECONDARY PROCEDURE WAS PERFORMED ON 18 MAR 2016 TO FIX A LEAK ASSOCIATED WITH NON-ENDOLOGIX ATRIUM STENTS, AND THE PATIENT WAS IMPLANTED WITH AN OVATION ILIAC LIMB.

  Patient problems: Not Applicable

  MAUDE report 7445695 ↗
• InjuryOct 10, 2017Failure To Adhere Or Bond; Leak/Splash; Improper or Incorrect Procedure or Method; Failure To Adhere Or Bond; Leak/Splash; Improper or Incorrect Procedure or Method

  THE PATIENT UNDERWENT AN EVAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM. A MEDTRONIC ENDURANT AORTA EXTENSION WAS IMPLANTED FIRST, THE AFX MAIN BODY WAS IMPLANTED AFTER. IT WAS REPORTED THE ENDURANT MAY HAVE MOVED DOWN FROM THE ORIGINAL IMPLANT POSITION. THE OVERLAP WAS NOTED TO BE SHORTER THAN PLANNED BETWEEN THE AORTIC EXTENSION AND AFX MAIN BODY. THE PHYSICIAN ELECTED TO BALLOON, HOWEVER A TYPE IIIA ENDOLEAK WAS OBSERVED. AN AFX SUPRARENAL CUFF EXTENSION WAS THEN IMPLANTED AT THE OVERLAP PORTION, HOWEVER THE TYPE IIIA ENDOLEAK WAS NOT RESOLVED. AS OF THIS REPORT, THERE HAS BEEN NO PATIENT SEQUELA REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 6938684 ↗
• InjuryJul 25, 2017Failure To Adhere Or Bond; Detachment Of Device Component; Leak/Splash; Patient-Device Incompatibility; Delamination; Failure To Adhere Or Bond; Detachment Of Device Component; Leak/Splash; Patient-Device Incompatibility; Delamination

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT, AN INFRARENAL AORTIC EXTENSION AND A LIMB EXTENSION. THE PATIENT CAME IN FOR A ROUTINE FOLLOW UP WHICH SHOWED THE PATIENT HAD A TYPE 3A ENDOLEAK WITH COMPONENT SEPARATION OF THE ILIAC LIMB AND THE MAIN BODY. THE PATIENT IS ALSO REPORTED TO HAVE ANEURYSM SAC GROWTH. THE PHYSICIAN ELECTED TO IMPLANT TWO ADDITIONAL LIMB EXTENSIONS TO SEAL THE ENDOLEAK. A FINAL PATIENT STATUS WAS NOT ORIGINALLY REPORTED TO ENDOLOGIX. TO DATE THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 6742503 ↗
• DeathSep 29, 2016Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  PATIENT HAD PREVIOUSLY REPAIRED ABDOMINAL AORTIC ANEURYSM PRIOR TO INITIAL AFX DEVICES IMPLANTED. ON (B)(6) 2016 THE PATIENT WAS IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION, PATIENT CONDITION PRIOR TO THE AFX IMPLANTS IS UNKNOWN. ON (B)(6) 2016 THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH ABDOMINAL PAIN AND ANEURYSM SAC GROWTH. COMPUTED TOMOGRAPHY (CT) SHOWED AN UNKNOWN ENDOLEAK AND IN ADDITION TO THE AFX MAIN BODY AND PROXIMAL EXTENSION, TWO NON-ENDOLOGIX DEVICES WERE ATTACHED TO THE LIMBS MAIN BODY. THE IMPLANT DATE OF THE LIMB EXTENSIONS IS UNKNOWN. PRIOR TO THE START OF THE ENDOVASCULAR REPAIR PROCEDURE THE ANEURYSM RUPTURED AND THE PATIENT HAD A LOSS IN BLOOD PRESSURE. THE ANGIOGRAM COULD ONLY CONFIRM AN UNKNOWN ENDOLEAK ABOVE THE BIFURCATION. DURING THE PROCEDURE THE PHYSICIAN FOUND THE PATIENT HAD A TORTUOUS ANATOMY WHICH MADE THE DEPLOYMENT OF THE REPAIR DEVICE, THE ADVANCEMENT OF THE DEVICE, AND THE WITHDRAW OF THE DEVICE DIFFICULT. THE PHYSICIAN WAS ABLE TO IMPLANT AN INFRARENAL AORTIC EXTENSION TO SEAL THE LEAK. AT THE COMPLETION OF THE PROCEDURE THE PATIENT HAD STABLE BLOOD PRESSURE, HOWEVER, THE PATIENT WAS AT RISK FOR ABDOMINAL COMPARTMENT

  Patient problems: Abdominal Pain; Aneurysm; Death; Rupture

  MAUDE report 5988869 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040002. One submission often covers many models, so check the product and lot details in each record.

• Z-1049-2017 · Jan 4, 2017 · Terminated
  AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F00820-06 BEA28-120/I16-40 F00820-07 B
• Z-1048-2017 · Jan 4, 2017 · Terminated
  AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C
• Z-1054-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-1038-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (A
• Z-1047-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoili
• Z-1039-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• Z-1037-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-0590-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• Z-0592-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• Z-0593-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• Z-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
• Z-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
• Z-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• Z-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL

…and 1 more.